Trial Outcomes & Findings for PREFER (Pacemaker Remote Follow-Up Evaluation and Review) (NCT NCT00294645)

NCT ID: NCT00294645

Last Updated: 2010-10-19

Results Overview

Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 980 participants
• Primary outcome timeframe: One year post-enrollment
• Results posted on: 2010-10-19

Participant Flow

Patients were enrolled from May 24, 2004 through March 30, 2007 at cardiology and electrophysiology clinics in the United States.

Of the 980 patients enrolled, 83 were excluded from analysis: incomplete informed consent forms (n=8), devices incompatible with the Medtronic CareLink® Network (n=7), from research centers that closed prior to cleaning data to the extent necessary for inclusion in cohort (n=67), and exited prior to Baseline assessment (n=1).

Participant milestones

Measure	Standard of Care With TTM Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Overall Study STARTED	295	602
Overall Study COMPLETED	247	510
Overall Study NOT COMPLETED	48	92

Reasons for withdrawal

Measure	Standard of Care With TTM Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Overall Study Death	10	18
Overall Study Lost to Follow-up	1	10
Overall Study Withdrawal by Subject	18	34
Overall Study Physician Decision	15	20
Overall Study Other	4	10

Baseline Characteristics

PREFER (Pacemaker Remote Follow-Up Evaluation and Review)

Baseline characteristics by cohort

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals	Total n=897 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	16 Participants n=7 Participants	25.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=5 Participants	169 Participants n=7 Participants	243.0 Participants n=5 Participants
Age, Categorical >=65 years	212 Participants n=5 Participants	417 Participants n=7 Participants	629.0 Participants n=5 Participants
Age Continuous	69 years STANDARD_DEVIATION 16.9 • n=5 Participants	68 years STANDARD_DEVIATION 16.7 • n=7 Participants	68 years STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants	290 Participants n=7 Participants	443.0 Participants n=5 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	312 Participants n=7 Participants	454.0 Participants n=5 Participants
Region of Enrollment United States	295 participants n=5 Participants	602 participants n=7 Participants	897.0 participants n=5 Participants

PRIMARY outcome

Timeframe: One year post-enrollment

Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months	35 Percentage of participants	47 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events Referral	0.005 Total number actions/total number CAEs	0.006 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events Office Visit	0.016 Total number actions/total number CAEs	0.043 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events Med Change	0.053 Total number actions/total number CAEs	0.05 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events Hospitalization	0 Total number actions/total number CAEs	0.012 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events ER Visit	0 Total number actions/total number CAEs	0.001 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events Device Reprogrammed	0.016 Total number actions/total number CAEs	0.028 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events System Modification	0 Total number actions/total number CAEs	0.009 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events Increase Monitoring	0.011 Total number actions/total number CAEs	0.009 Total number actions/total number CAEs
Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events Other	0.047 Total number actions/total number CAEs	0.031 Total number actions/total number CAEs

SECONDARY outcome

Timeframe: One year post-enrollment

Population: Only participants without a history of Atrial Tachycardia/Atrial Fibrillation were included in analysis of this objective.

Compare time to first diagnosis in Remote and Control arms

Outcome measures

Measure	Standard of Care With TTM n=139 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=282 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months	8 Percentage of participants	15 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Compare time to diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months	9 Percentage of participants	12 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Population: Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed vs other endpoint analyses.

Compare time to diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=266 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=557 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months	9 Percentage of participants	10 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Compare time to first diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months	4 Percentage of participants	8 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Compare time to first diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months	21 Percentage of participants	26 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Population: Analysis used subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.

Compare time to first diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=266 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=557 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Compare time to first diagnosis in Remote and Control arms

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months	0 Percentage of participants	1 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Population: Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.

Compare time to first diagnosis in Remote and Control arms

Outcome measures

Measure	Standard of Care With TTM n=266 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=557 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months	0 Percentage of participants	1 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Compare time to first diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months	1 Percentage of participants	1 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Population: Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.

Compare time to first diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=266 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=557 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Compare time to first diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months	1 Percentage of participants	1 Percentage of participants

SECONDARY outcome

Timeframe: One year post-enrollment

Compare time to first diagnosis in Control and Remote arms

Outcome measures

Measure	Standard of Care With TTM n=295 Participants Pacemaker patients followed by transtelephonic monitoring at 2 month intervals	Remote Pacemaker Interrogation n=602 Participants Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months	0 Percentage of participants	0 Percentage of participants

Adverse Events

Standard of Care With TTM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Remote Pacemaker Interrogation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CRDM Clinical

Medtronic CRDM

Phone: 800-328-2518

Email: medtroniccrmtrials@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PIs may not publish single-site data until the main multi-site publication has occurred.
• Publication restrictions are in place

Restriction type: OTHER